S9715, Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002999
Recruitment Status : Withdrawn
First Posted : July 5, 2004
Last Update Posted : May 27, 2015
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by:
Southwest Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with advanced cancer of the nasopharynx.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES: I. Gather additional information and experience regarding the preferred treatment from clinical trial SWOG-8892, chemoradiation for patients with advanced nasopharyngeal cancers (NPC). II. Evaluate survival and progression-free survival and patterns of tumor failure in this new group of patients. III. Assess severe or lethal toxicities that may be encountered after this regimen is employed more widely. IV. Collect NPC tumor specimens for ongoing and future clinical correlative research.

OUTLINE: Patients receive cisplatin by intravenous infusion on day 1 over a 15-20 minute period. This is repeated every 21 days for the first three initial treatments. Patients also receive radiation therapy once daily five times a week during this cycle of treatment. Approximately three weeks after completion of the above treatment, patients are given cisplatin by intravenous infusion over 15-20 minutes as above but at a lower dose. On the same day as cisplatin infusion, patients receive fluorouracil by continuous intravenous infusion over 24 hours for 4 days in a row. This is repeated every 28 days for a total of 3 treatments. Patients are followed until death.

PROJECTED ACCRUAL: 100 patients will be accrued.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: S9715, Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy, Phase II

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven nasopharyngeal carcinoma (excluding adenocarcinoma), stage III or IV with no evidence of distant metastatic disease (M0) No lung, bone, or liver metastases as proven within 42 days of registration by: -CT scan or nucleotide study of the chest or chest x-ray -liver and bone scan if alkaline phosphatase is greater than the institutional upper limit of normal (ULN), or if clinically indicated -liver scan if SGOT is greater than the institutional ULN

PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.6 mg/dL AND/OR Creatinine clearance at least 50 mL/minute Other: Not pregnant or nursing Women/men of reproductive potential must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No previous chemotherapy to the primary site or nodes Endocrine therapy: Not specified Radiotherapy: No previous radiotherapy (except for nonmelanomatous skin cancer outside of the radiation therapy treatment volume) Surgery: No previous surgery to the primary site or nodes

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002999

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study Chair: Muhyi Al-Sarraf, MD Providence Hospital
Study Chair: George L. Adams, MD Masonic Cancer Center, University of Minnesota

Responsible Party: Laurence H. Baker, D.O., Southwest Oncology Group-Group Chair's Office Identifier: NCT00002999     History of Changes
Other Study ID Numbers: CDR0000065552
U10CA032102 ( U.S. NIH Grant/Contract )
S9715 ( Other Identifier: SWOG )
First Posted: July 5, 2004    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Southwest Oncology Group:
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Nasopharyngeal Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs